LONDON and NEW YORK, Dec. 30, 2022 (GLOBE NEWSWIRE) — OKYO Pharma Limited (LSE: OKYO, NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical firm growing OK-101 to deal with Dry Eye Disease (DED) to handle the numerous unmet want on this multi-billion-dollar market, at this time proclaims its interim outcomes for the six months ended 30 September 2022.
During the previous six months the Group’s major focus has been centered on carrying out the submitting of the investigational new drug (IND) utility with the FDA on OK-101 to deal with DED.
During this era, the Group accomplished the next:
topical formulation of the OK-101 drug product in addition to preliminary stability studiesfinalized the bioanalytical technique improvement to help the OK-101 medical programbatch manufacture of cGMP OK-101 for medical trialstoxicokinetic technique developmenttoxicology research in rabbits and canines
Both nonclinical and medical improvement plans on OK-101 had been reviewed with the FDA in an earlier Pre-IND assembly in February 2022 facilitated by OKYO’s contract analysis group, Ora Inc, with the FDA agreeing to a first-in-human Phase 2 trial in DED sufferers. The FDA additionally concurred with OKYO’s plans for designating major and secondary efficacy endpoints overlaying each an indication and a symptom of DED within the trial’s medical protocol.
After appreciable effort over the previous 18 months, the Group introduced on 21 November 2022 the submitting of an IND on OK-101 with FDA to deal with DED sufferers. On December 22, 2022 the Group introduced that it had acquired FDA IND clearance for its deliberate Phase 2 trial in DED, which it expects to provoke in Q1 2023. The examine has been designed along with, and might be managed and monitored by Ora Inc, well-known for its management of ophthalmic medical trial actions. The Phase 2 trial is anticipated to be accomplished in 6-9 months from enrollment of the primary affected person.
On 6 August 2019, a collaborative settlement was signed with Pedram Hamrah, MD, Professor of Ophthalmology at Tufts University School of Medicine, Boston, MA to guage the Group’s BAM8-22 analogues, together with OK-201, as non-opioid analgesics to suppress corneal neuropathic ache utilizing a mouse ocular ache mannequin developed in Dr. Hamrah’s laboratory. Neuropathic corneal ache is a extreme, persistent and debilitating illness with no FDA authorized commercially out there remedies presently out there for this situation.
On 28 April 2021 the corporate introduced optimistic outcomes of OK-201, a non-opioid analgesic drug candidate delivered topically in Dr. Hamrah’s mouse neuropathic corneal ache mannequin, as a possible drug to deal with acute and persistent ocular ache. Importantly, OK-201 demonstrated a diminished corneal ache response equal to that of gabapentin, a generally used oral drug for neuropathic ache. These observations demonstrated preclinical ‘proof-of-concept’ for the topical administration of OK-201 as a possible non-opioid analgesic for ocular ache.
Although the outcomes with OK-201 had been encouraging, because of subsequent success obtained with OK-101 in follow-on animal mannequin research using the identical mouse neuropathic corneal ache mannequin, the corporate determined on the finish of 2021 to pause additional improvement of OK-201 to deal with ocular neuropathic ache, and to show its full consideration to the event of OK-101 to deal with DED.
During the previous six months the Group has halted any additional work on OK-201 because it focuses its full energies on acquiring IND clearance for OK-101 throughout the fourth quarter of 2022. This IND submitting was efficiently cleared and introduced on 22 December 2022.
Total property of £1.6 million (31 March 2022: £3.3 million)Cash available of £0.6 million (31 March 2022: £2.1 million)During the monetary interval below evaluate, the Company reported a complete complete lack of £4.6 million (in comparison with whole complete lack of £1.8 million for the six months ending September 30 2021)
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) (“UK MAR”). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) is a life sciences firm admitted to itemizing on NASDAQ and on the usual phase of the Official List of the UK Financial Conduct Authority and to buying and selling on the principle marketplace for listed securities of London Stock Exchange plc. OKYO is specializing in the invention and improvement of novel molecules to deal with inflammatory dry eye illnesses and persistent ache. For additional info, please go to www.okyopharma.com.
OKYO Pharma LimitedGary S. Jacob, Chief Executive Officer
+44 (0)20 7495 2379 Optiva Securities Limited
(Broker)Robert Emmet+44 (0)20 3981 4173 LifeSci Advisors
(Investor Relations)Irina KofflerIrina Koffler email@example.com
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